PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar
510(k) K200007
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK200007 | Date25 Apr 2020 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- LZO
- FDA applicant
- Microport Orthopedics, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3353
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Profemur Gladiator Thin HA Classic Hip Stem with Collar is a femoral component designed for total hip arthroplasty, classified as a hip prosthesis under regulatory nomenclature. It features a triple-tapered wedge geometry with a reduced lateral shoulder, facilitating tissue-sparing surgical techniques. Constructed with a collar, it is intended for secure fixation within the proximal femur.
This device is supplied sterile and intended for single-use in orthopedic surgery. It is approved under FDA 510(k) clearance (K200007) and MDR compliance, with a product code of LZO. The stem is available in a single design for primary hip replacement, adhering to orthopedic standards for hip stem fixation and stability.
From the manufacturer
Profemur® Gladiator® Hip Stems Triple taper stem philosophy Designed for primary hip replacement surgery, the Profemur® Gladiator® hip stem is a triple tapered wedge stem with a distinct geometry. The hip stem is designed with a reduced lateral shoulder convenient for tissue sparing techniques.
Manufacturer's product page: Five Things to Ask Your Surgeon
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of surgical techniques does the Profemur Gladiator Thin HA Classic Hip Stem support due to its design features?
The Profemur Gladiator Thin HA Classic Hip Stem is designed with a triple-tapered wedge geometry and reduced lateral shoulder, which specifically enables tissue-sparing surgical techniques. This means it allows surgeons to minimize soft tissue dissection while still achieving secure fixation in the proximal femur, reducing trauma to surrounding anatomy.
Is the Profemur Gladiator Thin HA Classic Hip Stem reusable, or is it intended for single-use only?
The device is explicitly intended for single-use in orthopedic surgery, as stated in its description. This aligns with standard practices for hip prostheses to ensure sterility and patient safety, avoiding risks associated with reprocessing or reuse.
What regulatory pathways does the Profemur Gladiator Thin HA Classic Hip Stem follow, and how does this affect its availability?
The stem is cleared under FDA 510(k) (K200007) with a substantially equivalent determination and complies with EU MDR (Medical Device Regulation). It is classified under product code LZO (hip prosthesis) and was reviewed by the Orthopedic (OR) Advisory Committee. These pathways confirm its regulatory compliance for use in total hip arthroplasty in both the U.S. and EU markets.
How is the Profemur Gladiator Thin HA Classic Hip Stem supplied, and what does this mean for surgical preparation?
The device is supplied sterile and packaged for single-use, meaning it arrives ready for immediate implantation without additional sterilization steps. Clinicians should verify the sterile packaging integrity before use and follow manufacturer guidelines for handling to maintain sterility until surgery begins.
Does the Profemur Gladiator Thin HA Classic Hip Stem come in multiple sizes, or is there only one design available?
The device is described as a single design for primary hip replacement, meaning it does not offer modular or interchangeable components (e.g., varying lengths or diameters). Its fixed geometry is optimized for standard proximal femur fixation, so surgeons should confirm compatibility with the patient’s anatomy preoperatively.